NU-PREP GEL
FDA 510(k) clearance K933798 · decided 1994-04-22
Clearance details
- K-number
- K933798
- Device name
- NU-PREP GEL
- Applicant
- Cadwell Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-04
- Decision date
- 1994-04-22
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- GXB
- Device class
- 1
- Regulation number
- 882.1500
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kennewick, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cadwell Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Medical Monofilament Sensory Screening Toool (K143068) | Medical Monofilament Manufacturing | 2015-01-14 |
| NEUROTIPS(TM) (K871571) | Ulster Scientific, Inc. | 1987-06-18 |
| ALGESIOMETER (K801907) | Rowan Products, Inc. | 1980-09-16 |
| AESTHESIOMETER (K772406) | Fred Sammons, Inc. | 1978-01-06 |
| TEMP-TESTER (K771847) | Jablecki, Charles, Dr. | 1977-11-02 |
| AESTHESIOMETER (K761133) | Fred Sammons, Inc. | 1976-12-02 |
Recalls involving this device
No recalls on record reference this clearance.